U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Bone Fixation - Product Code JEY
원인
Lack of device sterilization: an internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
조치
Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter.
100% of the consignees will be notified of the recall.
Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.